"A US Food and Drug Administration (FDA) advisory panel has backed a new biologic for psoriasis, though the panelists recommended strong warnings about the potential for suicide and self-injurious behavior (SIB) with the drug.
DOSAGE AND ADMINISTRATION
The recommended dose of AMEVIVE® is 15 mg intramuscularly once weekly for 12 weeks. The CD4+ T lymphocyte counts should be measured before initiating dosing.
AMEVIVE® therapy should not be initiated in patients who have CD4+ T lymphocyte counts below normal. The CD4+ T lymphocyte counts of patients receiving AMEVIVE® should be monitored every two weeks throughout the course of the 12-week dosing regimen. If CD4+ T lymphocyte counts are below 250 cells/µL, AMEVIVE® dosing should be withheld and weekly monitoring instituted. AMEVIVE® should be discontinued if the counts remain below 250 cells/µL for one month [see WARNINGS AND PRECAUTIONS].
An additional 12-week course may be initiated if at least 12-weeks have passed since the previous treatment course and the CD4+ T lymphocyte counts are normal.
- AMEVIVE® should be reconstituted using aseptic technique. Each vial is for single patient use only.
- AMEVIVE® 15 mg lyophilized powder should only be reconstituted with the supplied diluent (Sterile Water for Injection)
- Do not add other medications to solutions containing AMEVIVE®. Do not filter reconstituted solution during preparation or administration.
- Using the supplied syringe and one of the supplied needles, withdraw 0.6 mL of the diluent. Keeping the needle pointed at the sidewall of the vial, slowly inject the diluent into the vial of AMEVIVE®. Foaming will occur. Gently swirl the contents during dissolution. To avoid excessive foaming, do not shake or vigorously agitate. Dissolution of AMEVIVE® generally takes less than two minutes.
- Inspect AMEVIVE® reconstituted solution visually for particulate matter and discoloration. AMEVIVE® reconstituted solution should be clear and colorless to slightly yellow. The solution should not be used if it is cloudy, if there is pronounced discoloration, or if particulate matter is present.
- The reconstituted product should be used immediately or within 4 hours if stored in the vial at 2-8°C (36-46°F). Discard AMEVIVE® not used within 4 hours of reconstitution.
- The reconstituted solution should be clear and colorless to slightly yellow. Do not administer the solution if cloudy or discolored or if undissolved material or particulate matter is present.
- Remove the needle used for reconstitution and attach the other supplied needle. Withdraw 0.5 mL of the AMEVIVE® solution into the syringe, and inject the full 0.5 mL of solution intramuscularly. A volume of 0.5 mL of the reconstituted solution contains 15 mg of alefacept. Rotate injection sites so that a different site is used for each new injection. New injections should be given at least one inch from a previous injection site and never into tender, bruised, erythematous, or indurated skin.
- Discard empty vials of AMEVIVE®.
Dosage Forms and Strengths
For injection; AMEVIVE® is supplied as 15 mg of lyophilized powder in a single-use vial for reconstitution with Sterile Water for Injection, USP.
AMEVIVE® (alefacept) is a sterile, white to off-white, preservative-free lyophilizate (15 mg/vial) for intramuscular administration provided in single-use glass vials with a bromobutyl rubber stopper and an aluminum overseal. Each vial contains 15 mg of alefacept.
AMEVIVE® is available as follows:
| One- 5 mg single-use AMEVIVE® vial
One - 10 mL single-use diluent vial of Sterile Water for Injection, USP
One- 1 mL syringe
Two- 23 gauge 1 1/4 inch needles
| Four -15 mg single-use AMEVIVE® vials
Four -10 mL single-use diluent vials of Sterile Water for Injection, USP
Four- 1 mL syringes
Eight- 23 gauge 1 1/4 inch needles
Store AMEVIVE® refrigerated between 2-8°C (36-46°F). Do not freeze. Store in carton until use to protect from light.
AMEVIVE® (alefacept) Manufactured by: Astellas Pharma US, Inc. Deerfield,IL 60015. Revised: 05/2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/29/2016
Additional Amevive Information
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